||Covance Hosted Event
12:30 – 1:30 PM, Thursday, March 16, 2017
Title: Phase I cGMP Drug Manufacturing at the CRU: 3 Key Benefits
Speaker: Marcus Stavchansky, PharmD
Drug manufacturing can make up to 40% of the total cost to develop a new chemical entity and can be an inflexible, time consuming and frustrating experience during your first-in-human clinical trial. But it doesn’t have to when you use a cGMP pharmacy at your clinical research unit (CRU) for Phase I drug manufacturing. Our approach yields benefits in quality and safety, timeline reduction and cost efficiency.
Join us for an interactive session with Dr. Stavchansky, who led the design and implementation of the only cGMP pharmacy in a US CRU. He will share his experience and expertise to help you make informed decisions about the design, monitoring and control of your Phase I drug manufacturing.
Complimentary lunch will be provided.
Space is limited to the first 50 participants so reserve your place by sending your RSVP to email@example.com.
||PAREXEL Hosted Product Theater
12:00 – 1:00 PM, Friday, March, 17, 2017
Title: Current Best Practices for Safety in First-in Human Clinical Trials
Speaker: Edward Bernton, MD, Senior Director, Principal Consultant Early Phase
Complimentary afternoon refreshments provided.
Join PAREXEL Early Phase Services as they present a free, exclusive luncheon seminar, “Current Best Practices for Safety in First-in Human Clinical Trials.”
In this seminar Edward Bernton, MD will discuss the systematic approach to evaluating nonclinical data and protocol designs to mitigate risk in FIH will be described. The motivation and the impact of changes in EMEA guidances for FIH risk mitigation, expected in 2017, will also be discussed. PAREXEL’s experience evaluating over 500 proposed FIH studies will provide illustrations.
Edward Bernton, MD. is Principal Consultant of PAREXEL Early Phase Medical Sciences, responsible for Safety and Risk Mitigation reviews of FIH other potentially high-risk Phase 1 studies performed in PAREXEL’s five clinical pharmacology research units in the U.S., Britain, Germany, and S. Africa. His group of clinical pharmacology physicians works with sponsors on the design of efficient early phase studies, FIH through POC.
Space is limited to the first 50 participants so please reserve your spot by sending your RSVP to firstname.lastname@example.org.
||PRA Health Sciences Product Theater
9:00 – 10:00 AM, Friday, March 17, 2017
Title: Expediting Value Inflection by Early Clinical Learning
Speaker: Ewoud-Jan van Hoogdalem, Vice-President Global Scientific Affairs - Early Development Services at PRA International
Complimentary morning treats provided.
Join PRA as they present a free, sponsored seminar that will address the importance of development program design with the end-goal in mind, i.e. a target label claim that underscores the medical relevance of the novel product. More in particular, the presentation will address how an ambitiously tailored and feasible early clinical development plan expedites value building by early clinical learning. The message of the session will be reinforced with real-life case examples in different therapeutic areas, with one common theme: only a tailored early clinical development plan with studies that go beyond the standard package in the ‘usual healthy suspects’ maximizes informative value for the owner of the asset.
Space is limited to the first 50 participants so reserve your spot by sending your RSVP to email@example.com.